BEUDAMED
    FDA Registration Active 🇨🇳 China

    Jiangmen Dacheng Medical Equipment Co., Ltd.

    Reg #: 3010168054 · FEI: 3010168054 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    73
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Jiangmen Dacheng Medical Equipment Co., Ltd.
    Registration Number
    3010168054
    FEI Number
    3010168054
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    #8 South of Jiaobei Hengkeng, Jianghai District
    City
    Jiangmen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K221669

    Owner / Operator

    Firm Name
    Gentherm Medical LLC
    Operator Number
    10042384
    Address
    12011 Mosteller Road
    City
    Cincinnati
    State
    OH
    Postal Code
    45241
    Country
    US
    Correspondent
    Angie Gegner

    US Agent

    Business Name
    Gentherm Medical LLC
    Contact Name
    Jonathan Kovach
    Address
    12011 Mosteller Road
    City
    Cincinnati
    State
    OH
    ZIP
    45241
    Country
    US
    Email
    [email protected]
    Phone
    513 3265295

    Products

    Device Name Product Code
    System, Thermal Regulating DWJ

    Proprietary Names

    IOB Warming Blankets IOB-304/IOB-304S Extra Large Size Warming Suit IOB-001/IOB-001S Torso Warming Blanket IOB-028/IOB-028S Infant Under Body Warming Blanket IOB-002/IOB-002S Lower Body Warming Blanket IOB-014/IOB-014S Pediatric Long Warming Blanket IOB-024/IOB-024S Jackson Warming Blanket IOB-010/IOB-010S Spinal Under Body Warming Blanket IOB-005/IOB-005S Pediatric Under Body Warming Blanket IOB-006/IOB-006S Adult Under Body Warming Blanket IOB-030/IOB-030S Multi-position Upper Body Warming Blanket IOB-025/IOB-025S Infant Full Body & Under Body Warming Blanket IOB-003/IOB-003S Upper Body Warming Blanket IOB-021/IOB-021S XL Upper Body Warming Blanket IOB-303/IOB-303S Large Size Warming Suit IOB-027/IOB-027S Large Full Body Warming Blanket KoZee Under Body Warming Blanket, M21005 KoZee Small Warming Suit, M21301 IOB-018/IOB-018S Multi-Access Warming Blanket IOB-019/IOB-019S Dual Port Torso Warming Blanket IOB-015/IOB-015S Cath Lab Warming Blanket IOB-017/IOB-017S Chest Access Warming Blanket IOB-026/IOB-026S Large Half Body Warming Blanket KoZee Full Body Surgical Warming Blanket Postoperative, M21008 KoZee Lower Body Warming Blanket Pediatric, M21012 IOB-029/IOB-029S Lithotomy & Orthopedic Under Body Warming Blanket IOB-011/IOB-011S Lithotomy Under Body Warming Blanket IOB-023/IOB-023S Cardiac Warming Blanket KoZee Adult Full Body Warming Blanket Postoperative, M21004 KoZee Lithotomy&Orthopedic Under Body Warming Blanket, M21029 IOB-302/IOB-302S Medium Size Warming Suit KoZee Large Warming Suit, M21303 IOB-020/IOB-020S Cardiac Access Warming Blanket IOB-004/IOB-004S Full Body Warming Blanket KoZee Full Access Under Body Warming Blanket, M21006 IOB-008/IOB-008S Full Body Surgical Warming Blanket IOB-022/IOB-022S Outpatient Care Warming Blanket KoZee Full Body Warming Blanket Postoperative, M21007 IOB-007/IOB-007S Pediatric Full Body Warming Blanket IOB-012/IOB-012S Pediatric Lower Body Warming Blanket KoZee Long Warming Blanket Pediatric, M21014 IOB Temperature Management System Model IOB-507 IOB-009/IOB-009S Large Pediatric Under Body Warming Blanket KoZee Spinal Under Body Warming Blanket, M21010 IOB-301/IOB-301S Small Size Warming Suit KoZee Extra Large Warming Suit, M21304 KoZee Warming Unit M21507 IOB-034/IOB-034S Arms-in Upper Body Warming Blanket IOB-016/IOB-016S Surgical Access Warming Blanket KoZee Multi-Position Upper Body Blanket, M21030 KoZee Cardiac Access Warming Blanket Other, M21020 KoZee Medium Warming Suit, M21302 KoZee Cath Lab Warming Blanket Other, M21015 KoZee Surgical Access Warming Blanket Other, M21016 KoZee Lower Body Warming Blanket Intraoperative, M21002 KoZee Infant Under Body Warming Blanket, M21028 KoZee XL Upper Body Warming Blanket Intraoperative, M21021 KoZee Large Under Body Warming Blanket, M21009 KoZee Torso Warming Blanket Intraoperative, M21001 KoZee Infant Full Body & Upper Body Warming Blanket, M21025 KoZee Upper Body Blanket, M21003 IOB Warming Blanket KoZee Dual Port Torso Blanket, M21019 Lithotomy/Orthopedic Under Body Blanket IOB-029 Jackson Warming Blanket IOB-024 Extra Large Size Warming Suit IOB-304 Medium Size Warming Suit IOB-302 Large Half Body Blanket IOB-026 Large Size Warming Suit IOB-303 Small Size Warming Suit IOB-301 Infant Full Body/Under Body Blanket IOB-025 Infant Under Body Blanket IOB-028 Large Full Body Blanket IOB-027

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)